Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 2, 2020 | Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Minoxidil/Biotin 1.25mg/5mg Capsule, 90 capsules per bottle, MasterPharm, 115... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone Acetonide 0.01%/Finast... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Progesterone 300 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Libert... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Libe... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Calcium citrate tetrahydrate USP powder, 100 gm container, MasterPharm, 115-0... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty A... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle,... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... | CGMP Deviations | Class II | AAA Cosmetica, SA de CV |
| Jul 2, 2020 | Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty ... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty A... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 2, 2020 | Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave... | Lack of Processing Controls (lack of assurance of conformity to specifications). | Class II | MasterPharm LLC |
| Jul 1, 2020 | Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% to... | CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test ... | Class II | Preferred Pharmaceuticals, Inc. |
| Jun 29, 2020 | Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutane... | Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber ... | Class II | EMD Serono, Inc. |
| Jun 29, 2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... | FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... | Class II | RemedyRepack Inc. |
| Jun 25, 2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... | CGMP Deviations: Product was found to be below the label claim for ethanol content and the presen... | Class II | POLARIZED LLC |
| Jun 17, 2020 | Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage X... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... | Class II | Preferred Pharmaceuticals, Inc. |
| Jun 16, 2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (c... | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Jun 16, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| Jun 16, 2020 | Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (23... | Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Jun 13, 2020 | Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients:... | Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent ... | Class II | Yusef Manufacturing Laboratories, LLC |
| Jun 12, 2020 | Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl ... | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... | Class II | Beaming White Llc |
| Jun 12, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... | CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established... | Class II | The Harvard Drug Group |
| Jun 12, 2020 | Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed b... | Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 cou... | Class II | Aurobindo Pharma USA Inc. |
| Jun 12, 2020 | Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%)... | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... | Class II | Beaming White Llc |
| Jun 12, 2020 | Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70... | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... | Class II | Beaming White Llc |
| Jun 11, 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 11, 2020 | Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 11, 2020 | Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... | Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jun 10, 2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured ... | Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Class II | Crown Laboratories |
| Jun 10, 2020 | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured... | Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tabl... | Class II | Alembic Pharmaceuticals Limited |
| Jun 10, 2020 | Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured a... | Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. | Class II | Crown Laboratories |
| Jun 5, 2020 | metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 5, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Marksans Pharma Limited |
| Jun 5, 2020 | metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 4, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (ND... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | AVKARE Inc. |
| Jun 4, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | AVKARE Inc. |
| Jun 3, 2020 | Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz a... | Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a... | Class II | WALKER EMULSIONS INC |
| Jun 3, 2020 | Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (4... | cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specificat... | Class II | A.P. Deauville, LLC |
| Jun 3, 2020 | Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antisept... | Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a... | Class II | WALKER EMULSIONS INC |
| Jun 3, 2020 | Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradim... | Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. | Class II | Yusef Manufacturing Laboratories, LLC |
| Jun 2, 2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Teva Pharmaceuticals USA |
| Jun 2, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 620... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Teva Pharmaceuticals USA |
| Jun 1, 2020 | Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL... | Subpotent Drug: Product was found to be subpotent. Product also has high pH levels | Class II | WORLD EVENT PROMOTIONS, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
| May 29, 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only ... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Amneal Pharmaceuticals of New York, LLC |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.